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Roche Preparing New Diagnostic Product Launches for 2022 and Beyond


NEW YORK – On a conference call to discuss its financial results for the first quarter, Roche laid out its diagnostic test launches planned for the rest of the year and further down the line.

While some of those plans are related to COVID-19, Roche Diagnostics CEO Thomas Schinecker noted that many are part of the base business, which is expected to buoy the firm's sales as demand for COVID-19 testing decreases. The firm saw CHF 1.90 billion ($1.98 billion) in COVID-19 sales during the quarter, largely driven by point-of-care tests, but it anticipates that number to drop as the year continues and demand declines, Schinecker said. However, the base business has seen growth throughout the quarter and has quite a few product launches in the pipeline, he added.

Menu expansion in Roche's Serum Work Area solutions, which include the firm's Cobas analyzers, will help drive further base business growth. That segment has more than 100,000 installed instruments and a combined menu of more than 240 assays, including tests for vitamin D and viral hepatitis, as well as tests for Alzheimer's biomarkers in cerebrospinal fluid (CSF). 

Also in the Alzheimer's space, Roche is working on an Elecsys blood-based immunoassay panel, Schinecker said. Two biomarkers, phospho-tau 181 and ApoE4, have been selected out of about 20 different biomarkers based on clinical performance and sensitivity, with results on the markers expected to be unveiled at the Alzheimer's Association International Conference later this year. The biomarkers have also been used in Roche's Skyline study for its drug gantenerumab in pre-symptomatic Alzheimer's, and the panel test launch is planned to coincide with the drug launch, Schinecker said. 

The amyloid plasma assay is intended to be a triage test for selecting patients with a high likelihood of Alzheimer's undergoing initial testing and is expected to reduce the amount of people undergoing positron emission tomography (PET) scans and testing with cerebrospinal fluid by 65 percent to 70 percent, Schinecker said. PET scans are expensive and time-consuming, he added, so the panel test could be used to ensure people get treatment more quickly. 

Roche is currently planning clinical validation for the test panel to support in vitro diagnostic registration in major markets. The company also has Elecsys CSF tests, Elecsys beta-Amyloid CSF and Elecsys Phospho-Tau (181P) CSF, that serve as confirmatory assays for patients that have been sorted by the amyloid panel. The CSF tests have been approved as confirmatory tests outside the US, and Roche has plans to get approval in the US as well. The tests received breakthrough device designation from the US Food and Drug Administration in 2018 and have shown PET concordance, meaning they could be used to replace PET scans, according to Schinecker.

In addition to the Alzheimer's tests, Schinecker noted the upcoming launches of a duo hepatitis C test for antigens and antibodies to make diagnosis "faster and more precise," and an interferon gamma release immunoassay for SARS-CoV-2 to measure a patient's T-cell response.

On the molecular side, Schinecker touted the rise in installed base of the firm's Cobas 6800/8800 high-throughput instruments, which grew from 750 systems at the start of the pandemic to more than 1,900. The firm also recently launched its lower-throughput Cobas 5800 system in Europe, which is expected to have more than 500 placements by the end of 2022 and will eventually have the same test menu as 6800/8800. Schinecker noted that the Cobas 5800 targets a different customer segment and that Roche doesn't see a risk for cannibalization of the 6800/8800 systems as a result.

"We continue to see a very high demand across our molecular portfolio," he said.

The Cobas 6800/8800 instruments have multiple tests in development, including a multiplex respiratory panel and a SARS-CoV-2 duo PCR test. The duo test is both quantitative and qualitative, detecting not only the presence of SARS-CoV-2 but also measuring the viral load, and will run on all of the firm's molecular platforms, Schinecker said. He added that Roche will be submitting the test to US FDA for Emergency Use Authorization this week and that he expects it to help determine infectiousness, select therapy, and monitor therapy response.

Schinecker also provided more extensive updates on the COVID-19 business during the call, noting that the SARS-CoV-2 Rapid Antigen Test's EUA drove demand in the US and had a "very good impact" on the diagnostics business in Q1. However, he brought up the volatility in the rapid antigen test market, noting that a big portion of the business is governments making large orders of tests and that many governments won't continue making those orders as the year progresses and cases will likely decline. 

PCR testing in general, meantime, is a lot less volatile due to the higher volume of customers, but is still seeing declines in COVID-19, he said. 

Both rapid antigen tests and point-of-care Liat tests were "completely sold out" in Q1 and the company will continue to expand Liat's manufacturing capacity. Roche is also continuing to build out the test menu so it can "bring this platform to more parts of the world," he said. Roche expects the Liat POC and lab PCR businesses for COVID-19 will "sustain a bit longer," but at a lower level. 

As for other parts of the business, Schinecker declined to go into detail about ongoing programs related to mass spectrometry and sequencing but said that the company is "very committed" and "investing significantly" into the sequencing space. Roche has also made investments in the early cancer diagnostic arena, with Schinecker saying that the space will still see "a lot of developments ongoing." 

The "solutions that are on the market right now or going to be on the market … [are] not the end and the final answer," he said. "There is quite a big opportunity that we are interested in and that we are going to continue to monitor."